Kornimate/medical-research-clean huggingface dataset:
randomized trial of nordic walking vs. standard cardiac rehabilitation in patients with heart failure

Conditions: Heart Failure

Summary: the main purpose of our project is to see if a 12-week program of nordic walking is better than standard exercise therapy for increasing exercise capacity (measured by how far people can walk in 6 minutes) and increasing quality of life (measured by having people fill out two questionnaires). we will also see if nordic walking: improves heart performance (measured by heart ultrasound); improves how active people are (measured by an activity monitor); increases aerobic fitness (measured by a treadmill test); improves body composition (measured by waist size); and reduces hormone levels in the blood.

a single-site, parallel-group, randomized controlled trial will be conducted (appendix c) at the university of ottawa heart institute (uohi). patients with stable hf referred to cardiac rehabilitation will undergo baseline assessment and then be randomly assigned (1:1) to either standard exercise therapy (consisting of regular walking and a resistance exercise program) or nordic walking. follow-up measures will be taken at the end of intervention (12 weeks) and after a 14-week no-intervention observation period (26 weeks). after initial randomization to treatment group, participants will be stratified by treatment group and randomly assigned to one of three follow-up measurement conditions at 12 weeks: echocardiograph and cardiopulmonary test (n=80); cardiopulmonary test only (n=60); or no follow-up echocardiograph or cardiopulmonary test (n=76). the primary outcomes will be: a) changes in exercise capacity measured by 6mwt; and b) changes in disease-specific hrql measured by the mlhfq. additional measures will examine the effects of the exercise interventions on: cardiac performance; leisure time activity; cardio-respiratory fitness; body composition; neurohormonal activation; and generic hrql

Eligibility criteria:
inclusion criteria: * patient has a confirmed diagnosis of hf based on a hf admission and/or a clear diagnosis of hf and/or reduced ejection fraction (≤45% measured by echocardiography within the last six months); * patient is referred to cardiac rehabilitation program; * patient is willing to attend an onsite cardiac rehabilitation program twice weekly for 12 weeks; * in the opinion of the referring physician, the patient is medically stable, and able to participate in an exercise program * patient is able, in the opinion of the qualified investigator, to comprehend and participate in the exercise intervention; * patient is 18 years of age or older; * patient is willing to provide informed consent. exclusion criteria: * patient is unable to read and understand english or french * patient intends to begin cardiac rehabilitation within the next 6 weeks * patient is unwilling or unable to return for follow-up visits at 12 and 26 weeks; * patient is currently using nordic walking poles.
neuroimaging of opioid phase (opal)

Conditions: Chronic Pain; Opioid Use

Summary: the purpose of this study is to compare activity in the brains of female adults with chronic pain and/or opioid use, and healthy female adults that may help to develop new and targeted treatments for adults with chronic pain and alternatives to opioid therapy.

the objective of the study is to determine differences in neurophysiology and behavior during different phases of opioid use in patients. study activities will include neuroimaging (mri and fmri), behavioral tasks, sensory testing, blood draws, and questionnaires. the neuroimaging data will be analyzed using specialized software; data from questionnaires, sensory testing, and behavioral task performance will be analyzed using standard statistical software. risks and safety concerns include standard, minimal risks associated with mri scans, sensory testing, blood draws, and confidentiality.

Eligibility criteria:
inclusion criteria for healthy controls: 1. female and ages 18+ 2. ability to read/understand english and give consent to participate 3. no current or history of chronic pain 4. not regularly taking any pain-relieving or mood-altering medications (per pi discretion) 5. absence of use of opioid medications inclusion criteria for individuals with chronic pain: 1. female and ages 18 + 2. ability to read/understand english and give consent to participate 3. self-reported or physician diagnosis of fibromyalgia and/or chronic pain 4. current use of opioid medication(s) for inclusion in the opioid patient group -or- absence of use of opioid medications for inclusion in the non-opioid patient group exclusion criteria (for both groups): 1. limited ability to participate fully in behavioral tasks, longitudinal follow-up 2. mri contraindication 3. any factors that at the discretion of the investigators would adversely affect the participant or the integrity of the study 4. male

Keywords: fibromyalgia women brain functional mri opioid opiate narcotic chronic pain pain
a dosing study of hyperbaric oxygen therapy (hbot) on epigenetic aging

Conditions: Aging

Summary: this study aims to assess the impact of hyperbaric oxygen therapy on a number of outcomes, including epigenetic aging, inflammation, and cellular health.

while current research has identified many mechanisms of action, effects and cell signaling benefits resulting from hbot, we do not have a firm understanding of the timeframe and dosage for many of these expected adaptations. data from this study will be collected and shared on an ongoing basis throughout the course of care. this research project will help us to confirm these cell-signaling changes and benefits, and also develop a better understanding of the necessary po2 and time frame required in order to achieve these changes leading to improved patient outcomes in the field of hyperbaric medicine.

Eligibility criteria:
inclusion criteria: 1. any sex, gender orientation, and ethnicity 2. between ages 40 and 70 3. must be willing and able to participate in venipuncture, health history and clinical assessments, lab test assessment, hyperbaric oxygen treatment. 4. participants must also agree to maintain their current lifestyle choices consistent with pre- participation with this study. participants should not change their exercise programs, diets, sleep patterns supplements or other. any significant changes in their lifestyle choices must be reported to the staff. exclusion criteria: 1. significant change in diagnosis and/or treatment of major illness or injury within 2 years prior to screening, e.g., diabetes, cancer, cardiovascular disease, psychiatric condition 2. any ongoing immune system concerns or immunodeficiency disease 3. body mass index (bmi) changes of more than 5% over the course of the study 4. changes in weight of more than 15 lbs. during the course of the study 5. presence of a severe active infection as determined by the principal investigator. 6. any other illness, disorder, alcohol or chemical dependence that in the opinion of investigators would render study participation unsuitable 7. unable or unwilling to provide required biological sample 8. unable or unwilling to avoid pregnancy during study period 9. presence of cataracts before the study begins 10. myopic changes within the first 30 days of treatment
witnness - tnnt1 myopathy natural history study

Conditions: TNNT1-associated Myopathy; Infantile-onset Nemaline Rod Myopathy; Myopathies, Nemaline; Myopathy; Myopathy, Rod; Myopathy; Hereditary; Amish Nemaline Myopathy; Nemaline Myopathy 5; NEM5; Genetic Muscle Disease; Recessive Hereditary Disorder (Autosomal); ANM

Summary: witnness is designed to accurately document the natural course and variation of muscle disease caused by pathogenic changes of the tnnt1 gene. the primary aim of the study is to specify meaningful outcome measures for future clinical trials. witnness is open to children and adults worldwide. participants can choose to include their information once (cross-sectional cohort) or every few months (prospective cohort).

witnness is an observational study that includes prospective and cross-sectional arms, both of which include people diagnosed with autosomal recessive tnnt1-associated muscle disease, commonly described as a form of infantile-onset (nem5a) or childhood-onset (nem5b) nemaline rod myopathy. the study's primary objective is to establish the nature and time course of disease outcomes under current treatment, so that these can later be compared to outcomes achieved with novel disease-modifying therapies (i.e., interventional trials). participants from all over the world are welcome to enroll in either arm of the witnness study. following appropriate consent, those in the prospective arm are followed long-term. recurring assessments are performed at the participant's home, the clinic for special children, or a partnering clinical site, depending on the individual's particular circumstances. basic assessments include vital signs, a physical exam, documentation of motor milestones, growth measurements, and blood chemistry values. participant's may also undergo non-invasive ultrasound of the heart (echocardiogram) and one or more chest radiographs. participants in the cross-sectional arm are contacted once after consent. members of the witnness study team partner with healthcare providers and family members to capture pertinent medical history, physical exam findings, growth metrics, and motor milestones at the time of contact.

Eligibility criteria:
inclusion criteria: * diagnosed with biallelic pathogenic variants of tnnt1 * infantile-onset or childhood-onset proximal weakness without confounding medical conditions that could effect muscle health. exclusion criteria: * another known or suspected medical condition (genetic or acquired) that could potentially alter the natural disease course or otherwise interfere with completion of study procedures.
a study to evaluate tislelizumab combined with sitravatinib as adjuvant therapy in participants with hcc at high risk of recurrence after curative resection

Conditions: Hepatocellular Carcinoma

Summary: this is an open label, multi-center, single arm study to evaluate the efficacy and safety of tislelizumab combined with sitravatinib as adjuvant therapy in hepatocellular carcinoma (hcc) patients who are at high risk of recurrence after curative resection.

hepatocellular carcinoma (hcc) is a malignant tumor with high morbidity and mortality. surgical resection is the most important radical treatment. however, the recurrence rate is high especially in the patients with high risk of recurrence after curative resection. how to reduce postoperative recurrence and improve survival is currently a direction that is worth exploring. until now there is no standard postoperative adjuvant therapy. various adjuvant treatment methods including immunotherapy, targeted therapy, tace are being studied. this study is to explore the efficacy and safety of tislelizumab combined with sitravatinib as adjuvant therapy in hcc patients who are at high risk of recurrence after curative resection.

Eligibility criteria:
inclusion criteria: 1. subjects with a histopathological or cytologically diagnosis of hcc 2. subjects who have undergone a curative resection 3. high risk for hcc recurrence as protocol defined 4. no previous systematic treatment and locoregional therapy for hcc 5. child-pugh score, class a 6. ecog performance status 0 or 1 7. full recovery from surgical resection 8. adequate organ function 9. absence of major macrovascular invasion 10. no extrahepatic spread 11. life expectancy of at least 6 months exclusion criteria: 1. known fibrolamellar hcc, sarcomatoid hcc or mixed cholangiocarcinoma and hcc 2. evidence of residual, recurrent, or metastatic disease 3. known history of serious allergy to any component of tislelizumab or sitravatinib preparations 4. history of hepatic encephalopathy 5. tumor thrombus in portal vein or superior mesenteric vein or inferior caval vein 6. portal hypertension with bleeding esophageal or gastric varices within 6 months prior to initiation of treatment 7. any bleeding or thrombotic disorder within 6 months prior to initiation of treatment 8. any active malignancy within 2 years prior to the start of treatment 9. active or history of autoimmune disease 10. other acute or chronic conditions, psychiatric disorders, or laboratory abnormalities that may increase the risk of study participation 11. pregnant or lactating women
a study of brain imaging with nuclear medicine technology in individuals with and at risk for parkinson's disease

Conditions: Parkinsonian Syndrome

Summary: this study involves study participants who have been clinically diagnosed with parkinsonian syndrome or who are at-risk for parkinsonian syndrome, have a family history of parkinsonian syndrome or exposure to environmental toxins potentially associated with parkinsonian syndrome. participants will have brain imaging to assess dopamine transporter density. the imaging data coupled with family history and environmental exposure data may provide important information about potential risk factors for parkinsonian syndrome.

the brain imaging is conducted at the institute for neurodegenerative disorders in new haven, connecticut. the imaging procedure occurs over a two day period. on the first day participants are injected with \[123i\]ß cit, an investigational radioactive material that localizes in the brain. study participants will also have a thorough neurologic examination and standard neuropsychological testing, including testing of memory, concentration, abstraction and visual spatial functions. twenty-four hours later study participants return to the institute for neurodegenerative disorders where an investigational scanning procedure will be used to obtain spect (single photon emission computed tomography) images of the brain. participants may be contacted to repeat these procedures every 12 to 18 months.

Eligibility criteria:
inclusion criteria: * 22 years or older * a clinical diagnosis of parkinson's disease (pd), positive family history of pd and/or potential exposure to environmental toxins * normal screening laboratory studies exclusion criteria: * pregnancy * psychiatric disease other than history of depression * significant medical disease including abnormalities on screening

Keywords: parkinson family history diagnosis
study to predict lanreotide-induced disease activity normalization in acromegaly

Conditions: Acromegaly

Summary: the purpose of the study is to collect data about predictive factors for the efficacy of lanreotide autogel in patients with acromegaly in routine clinical practice.


Eligibility criteria:
inclusion criteria: * male or female aged 18 years and older with the capacity to consent * signed written informed consent * subject with hormonally active acromegaly defined by locally measured igf-i levels 1.3 times above the age- and sex-adjusted normal range as determined at the last routine visit before baseline and after surgery * subject with the intention to be treated with lanreotide autogel according to the current local smpc (germany, austria) prior to study enrolment exclusion criteria: * participation in an interventional trial at the same time and/or within 3 months before baseline * subject represented by a legal guardian
healthcare resource utilization and costs in metastatic melanoma patients initiated dabrafenib + trametinib and encorafenib + binimetinib

Conditions: Metastatic Melanoma

Summary: this was a retrospective cohort study using the marketscan health care administrative claim databases: truven health analytics' marketscan commercial claims and encounters; marketscan medicare supplement and coordination of benefit. we conducted this analysis using the most recent available data from the marketscan database at the time of analysis, which was 01 june 2018 to 31 december 2020. we initiated this analysis from 01 june 2018 as encorafenib + binimetinib (enco/bini) was approved for patients with unresectable or metastatic melanoma with braf mutation at this time.


Eligibility criteria:
inclusion criteria: * at least one diagnosis of malignant melanoma (the international classification of diseases, 9th revision \[icd-9\] codes: 172.0-172.9 or v10.82; icd-10 codes: c43.0 c43.10 c43.20 c43.30 c43.31 c43.39 c43.4 c43.59 c43.60 c43.70 c43.8 c43.9 d03.0 d03.10 d03.11 d03.12 d03.20 d03.21 d03.22 d03.30 d03.39 d03.4 d03.51 d03.52 d03.59 d03.60 d03.61 d03.62 d03.70 d03.71 d03.72 d03.8 d03.9 z85.820) in the study period. * a diagnosis of metastasis (icd-9 196.x, 197.x, 198.x, 199.x \& icd-10 c77.xx, icd-10 c78.xx, icd-10 c79.xx, icd-10 c80.xx) within 30 days before or 60 days after their malignant melanoma diagnosis. * a prescription (pharmacy or medical claim) of enco/bini or dab/tram as a 1l therapy after the metastatic melanoma diagnosis date. * at least ≥18 years as of the index date. * at least 6 months of continuous enrollment before index date and 6 months after index date. exclusion criteria: * patients with a diagnosis of other primary malignancy (icd-9: 140.xx-165.xx, 170.xx-171.xx, 173.xx-195.xx, 200.xx-208.xx; icd-10: c00.x - c14.x, c41.x, c49.x, c50, c51) during the 6 months pre-index period. * patients with pregnancy (icd-9: 630.xx-679.xx, v22.xx-v24.xx, v27.xx-v28.xx; icd-10: o00 - o99) any time during the study period. * patients with more than one melanoma-related drug prescription other than the index drug, on the index date.
esophagus-sparing radiotherapy for metastatic spinal cord compression.

Conditions: Metastatic Spinal Cord Compression; Radiation Toxicity; Esophagitis; Patient Reported Outcome Measures

Summary: metastatic spinal cord compression (mscc) is a serious complication to metastatic cancer and when diagnosed life expectancy is short. treatment is palliative radiotherapy (rt). early esophageal toxicity is underreported but can seriously impact quality of life (qol). the aim of the eso-spare trial is to investigate if esophagus sparing rt can decrease patient reported esophageal toxicity without compromising ambulatory function or increase other toxicities. 200 patients with mscc in the thoracic or cervical spine referred for rt will be randomized to either standard or esophagus/pharynx sparing rt. subsequently participants will be followed with prom (patient reported outcome measures) for 9 weeks. prom-ctcae questionnaires on upper gi toxicity and pain will be collected daily for 5 weeks and weekly for 4 weeks. questionnaires evaluating qol and physical function will be collected weekly for 9 weeks.


Eligibility criteria:
inclusion criteria: * histology or cytology proven cancer * referred for palliative radiotherapy of the cervical or thoracic vertebra for * epidural ingrowth * metastatic spinal cord compression * metastatic spinal nerve root compression * post-operative radiotherapy after decompressive surgery for spinal cord or nerve root compression * ability to understand and the willingness to sign a written informed consent document * referred for the following dose prescriptions 5 gy x 5, 5 gy x 4, 3 gy x 10, 10 gy x 1, 8 gy x 1. * ≥ 18 years old. exclusion criteria: - referred for \> 10 fractions

Keywords: metastatic spinal cord compression radiation toxicity esophagitis patient reported outcome measures palliative radiotherapy
heart outcomes prevention and evaluation 4

Conditions: Hypertension; Cardiovascular Disease

Summary: the overall objective of the hope-4 phases (ht and cvd) is to develop, implement and evaluate an evidence-based, contextually appropriate programme for cardiovascular disease (cvd) risk assessment, treatment and control involving: (1) simplified algorithms implemented by non-physician health workers (nphw) and supported by e-health technologies (tablets programmed with decision and counselling support software); (2) initiation of evidence-based cardiovascular (cv) medications and (3) treatment supporters to optimize long-term medication and lifestyle adherence.

study design: open-label, parallel cluster randomized controlled trial design. ht phase: up to 30 urban and rural communities in canada, colombia and malaysia will be randomized to participate in an intensive cv risk detection and control programme by nphw or to care as usual for 12 months. note: canada will serve as a pilot study, which will be used to evaluate feasibility, time, cost and program improvements. cvd phase: if funded, this phase will be a continuation and expansion of ht phase to include up to 190 urban and rural communities in countries within asia, south america, sub-saharan africa, and canada that will be allocated to participate in an intensive cv risk detection and control programme supported by nphws or to care as usual for up to 6 years. note: cvd phase - currently not initiated. communities will be randomized 1:1 with a central randomization system to either a) intervention or b) control, after screening in the community is complete.

Eligibility criteria:
inclusion criteria: individuals (≥ 50 years) with at least one of the following criteria: 1. sbp ≥160 mmhg in one visit 2. sbp 140-159 mmhg in one visit and participant-reported medical diagnosis of hypertension 3. sbp 140-159 mmhg in one visit and participant taking anti-ht medication 4. sbp ≥130 mmhg in one visit and participant-reported medical diagnosis of diabetes 5. sbp ≥130 mmhg in one visit and participant taking medication for diabetes 6. participants that do not meet criteria 1-5 and sbp 140-159 mmhg in one visit and sbp ≥140 mmhg in a second visit ≥24 hours apart exclusion criteria: 1. refusal to consent 2. actively involved in any study or heart health program that would compromise the protocol of hope-4 3. severe co-morbid condition with life expectancy \< 1 year 4. other serious condition(s) or logistic factors likely to interfere with study participation or with the ability to complete the trial, as appropriate to country or region.
phase 2 study of abx-egf (panitumumab) in japanese subjects with m-colorectal cancer

Conditions: Metastatic Colorectal Cancer

Summary: the primary objective of this study is to assess the effect of treatment with abx-egf on best overall objective response rate by modified recist (confirmed complete or partial response) in japanese subjects with metastatic colorectal cancer.


Eligibility criteria:
inclusion criteria: * metastatic colorectal adenocarcinoma; * subjects must have become refractory to treatment or unable to continue treatment due to toxicity or other reasons during or after treatment with fluoropyrimidine, irinotecan and oxaliplatin for metastatic colorectal cancer including those who relapsed during or within 6 months from the completion of adjuvant therapy using the above agents; - tumor expressing egfr levels by immunohistochemistry (membrane staining must be positive in 1% of evaluated tumor cells). exclusion criteria: * subjects who have prior experimental or approved antibodies (eg, bevacizumab) within 3 months before enrollment; * subjects who have prior egfr targeting agents; * chemotherapy other than fluoropyrimidine (including oral agents such as uft, ts-1), irinotecan, and oxaliplatin (or raltitrexed) for colorectal carcinoma in accordance with specified regimens (leucovorin and levamisole are not considered as chemotherapy

Keywords: egfr fully human monoclonal antibody panitumumab abx-egf amg954 colorectal cancer japan